Medical Device UKRP Service
Overview
If you are placing medical devices or IVDs on the UK market but are based outside the UK, appointing a UK Responsible Person (UKRP) is a legal obligation — not an option.
At MEDRA, we are fully qualified to act as your UK Responsible Person for medical devices. As your trusted UKRP, we will:
Register your devices with the MHRA (Medicines and Healthcare products Regulatory Agency).
Verify that the Declaration of Conformity and Technical Documentation are complete and compliant.
Maintain copies of your technical documentation and make them available to the MHRA upon request.
Provide any required information to the MHRA promptly and accurately.
Notify you of any complaints or adverse incidents relating to your devices.
Represent your company within the UK market.
Starting from 1st January 2022, under the UK MDR 2002 regulations, it is a legal requirement for medical device manufacturers based outside the UK to appoint a UK Responsible Person (UKRP). The UKRP will act on the manufacturer’s behalf when interacting with UK regulatory authorities. This appointment is mandatory for manufacturers to place their medical devices on the market in Great Britain.
Why Choose MEDRA to Be Your UKRP?
Complete Compliance Support:
Our team of seasoned consultants is here to dive deep into the world of UK medical device regulations, offering not just guidance, but a real understanding of the ins and outs. We make sure you’re always in the loop with the latest changes, helping you navigate the regulatory maze effortlessly.
Personalised to Your Business:
We understand that every business is unique. That’s why we take the time to truly learn about your specific needs, challenges, and goals. Our services are never one-size-fits-all — we customise our support to align perfectly with what works best for you.
We’re In it Together:
We believe in building genuine, lasting relationships with our clients. You won’t find stiff, formal interactions here — we prioritise open communication and true collaboration. Think of us as an extension of your team, providing ongoing support and expert guidance to help you stay ahead with your regulatory compliance.
Reviewing Your Regulatory Documentation
Our experienced team thoroughly reviews all your technical documentation — including risk management files, labelling, and instructions for use — to ensure everything fully complies with UK regulatory requirements.
Choosing the right UK Responsible Person (UKRP) for medical devices is a critical decision for any manufacturer. You need a trusted partner who can represent you effectively with the UK MHRA and ensure your compliance obligations are met.
Working with an independent UKRP — one that is not tied to your existing distribution or import arrangements — helps protect your market access and avoids any potential conflicts of interest. By appointing MEDRA as your UKRP, you meet this best practice and gain peace of mind.
But we don’t stop at fulfilling the core responsibilities. We go further, keeping you updated on any regulatory changes that could impact your business. We also provide expert advice on your regulatory pathway for securing a CE Mark or UKCA Mark, helping you navigate the process smoothly and reach the market with confidence.
Need help with regulatory strategy?